Unintended pregnancy and STDs present serious health and social consequences for individuals and society at large. Known prevention and protection measures have reduced these problems to some extent. Male condoms are a well-known form of a barrier device that provide varying degrees of protection against unintended pregnancy and STDs. Male condoms, however, generally require the male partner to initiate use after an erection has been attained, thus frequently causing an awkward disruption of intimacy and foreplay. Additionally, many women would prefer not to have to rely on their male partner to provide their protection. Male condoms are disliked for a variety of additional reasons, including reduced sensation for the male partner.
Problems associated with male condoms have led to the development of various forms of female condoms that a woman can pre-place in her vagina before intercourse. Unlike a conventional diaphragm or cervical cap, which covers only a region of the vagina near the cervix or the cervix itself, known female condoms generally provide a tubular receptacle extending along the length of the vaginal canal and extending over all or some of the genitals, thereby fully encompassing an inserted penis and affording increased protection. Such devices advantageously empower a woman to protect herself from unintended pregnancy and STDs, without reliance on the male partner.
While known female condoms provide a level of protection and advantage over conventional male condoms, they do not present an ideal solution. Several problems can be identified. Some female condoms are difficult to use and others may be uncomfortable for some women. Both of these problems may reduce the pleasure of intercourse for both the male and the female partner. With many designs, the outside portion of the female condom may shift and twist excessively prior to and during initiation of intercourse. This may require the woman to hold the outside portion with one or both hands during penis insertion, which can be disruptive and awkward. A related problem of known female condoms is a lack of stability of the condom within the vaginal canal. The condoms may move around, and fall partially out, or a portion intended to remain outside of the vagina may be pushed inside. This lack of stability compromises barrier protection, and may make both partners feel nervous and insecure during intercourse. The movement of the pouch with the penis also decreases sensation of the male partner.
Hessel U.S. Pat. Nos. 5,490,519 and 5,623,946 disclose tubular devices worn by a female for protection against transfer of infectious matter during sexual intercourse. This general type of condom is available commercially as the REALITY condom. These tubular devices have an open end defined by a first ring, and a second closed end to be positioned at the distal end of the vagina. The internal tubular portion of the condom is designed to be retained by retaining means positioned at the closed end, e.g., a second ring. The second ring is oriented at an acute angle relative to first ring, and is designed to wedge or anchor around the cervix in a manner similar to a diaphragm. In use, this ring may slip away from its anchor point and permit a portion of the front part of the condom to hang or dangle outside of the woman user. Also, because the retaining means acts at the distal end of the vagina, security of the first (outer) ring is dependent on the length of the vaginal canal.
Evans et al. U.S. Pat. No. 4,945,923 also discloses a tubular contraceptive device to be worn by a woman. The device includes an outer ring and an inner ring positioned at a closed distal end of the device. The inner ring, like the Hessel devices, is designed to anchor the bottom end of the device around the cervix of a user. It is similarly susceptible to slippage from its cervical anchor point, and twisting or displacement during use.
Another type of female condom is commercially available, which is known as the V'Amore condom. The V'Amore condom is manufactured in India and has a design generally similar to the REALITY condom. An outer (proximal) ring of the V'Amore condom is shield-shaped, and retention of an inner pouch is provided by a sponge that is intended to lodge somewhere in the distal region of the vagina near the cervix. The V'Amore condom likewise may lack stability within the vaginal cavity, and does not assure close stable positioning of the outer shield.
Another known type of female contraceptive device is known as a panty condom. While providing external stability, these devices do not adequately address the need for stability of the condom pouch within the vagina. A pouch portion of the panty condom is inserted into the vagina, which may pull inside out, or twist or turn. This can adversely affect male partner sensation and compromise barrier protection. Additionally, with known panty condoms, air tends to be pumped into the vaginal cavity during intercourse. This can be noisy and uncomfortable for the woman. After intercourse, the devices may turn inside out during withdrawal, thereby making a mess and increasing the potential for disease transmission and unintended pregnancy. Additionally, the panty configuration may be objectionable to users for aesthetic reasons.
Artsi et al. U.S. Pat. No. 5,515,862 discloses a female condom generally similar to the aforementioned panty arrangement. The device has an extensive external shield, which is adhesively applied to cover pubic, abdominal, groin, thigh and anal regions, and a flexible tube extending from the shield to a closed end. Multiple rings are positioned along the length of the tube. One ring is used at the closed end to anchor around the cervix, similar to a diaphragm, and additional rings placed along the length of the tube are intended to lodge against the muscular tissue of the vaginal passage, to prevent slippage of the tube along the length of the vagina during use. The disclosed “semi-rigid” intermediate rings may to some extent improve stability of the tube in the vagina canal, yet no guidance is provided with respect to a positioning, sizing or configuration of the intermediate rings to maximize internal/external condom stability. Additionally, multiple rings positioned along the length of the condom may be encountered by a man's penis during intercourse, thus causing discomfort to the male partner.
Commonly assigned co-pending U.S. application Ser. No. 09/921,016, published under No. US-2002-0038658-A1 on Apr. 4, 2002 (the '658 application), discloses “tensegrity” based female condom designs. The disclosure of that application is incorporated herein by reference. According to aspects of the '658 application, tensegrity-based female condoms employ compression and tension forces to provide substantial stability of the female condom. As such, when a tensegrity-based condom is inserted into a woman's vagina, the woman's introitus acts on a proximal section of an elongated pouch extending between internal and external biasing members (e.g., rings) of the condom. Inward compressive forces exerted by the introitus on the inner ring of the condom cause the inner ring to be pushed distally within the vaginal canal, and the proximal pouch section to become a tension member pulling against the external ring. This causes a “tenting” of the proximal pouch section against the introitus.
Tensegrity-based female condoms can provide a high degree of internal and external stability; however, the degree of stability may vary depending on the depth of tissue of the user's introitus. In other words, the degree of stability may vary for different sizes of women.
The '658 application further discloses an embodiment of a tensegrity-based female condom that includes pads of resilient material, such as foam, that form an internal biasing member of the condom. The pads may be placed on the outside of pouch material and may be made of hydrophilic polyurethane, which provides mucosal cling to the user's vaginal walls. The mucosal cling acts to increase stability of the female condom, and/or reduce reliance on the spring action of the pad material (i.e., internal biasing member) to maintain the intermediate section of the pouch expanded against a distal portion of the introitus. Thus, hydrophilic pads act in concert with the tensegrity principle to provide condom stability. Depending on its size, a tensegrity-based female condom is applicable to women having an introitus' depth within a given range.